Selinexor shows potential in dedifferentiated liposarcoma
Patients with advanced, refractory dedifferentiated liposarcoma (DD-LPS) treated with selinexor showed improvement in progression free survival (PFS) and time to next treatment compared with patients treated with placebo, according to a study.
In this phase 2/3, multicenter, randomized, double-blind, placebo-controlled study, 285 patients ≥12 year of age with advanced DD-LPS who had received 2 to 5 lines of therapy were included. Patients were randomly assigned (2:1) to 60 mg of selinexor (n = 188) or placebo (n = 97) twice weekly in 6-week cycles (crossover permitted). The primary end point was progression-free survival (PFS).
The median PFS and time to next treatment was 2.8 months and 5.8 months, respectively, in the selinexor group compared with 2.1 months and 3.2 months, respectively, in the placebo group (95% CI, 0.52 to 0.95; one-sided P = 0.011 and 95% CI, 0.37 to 0.66; one-sided P < 0.0001).
There was no difference observed in overall survival with crossover.
Treatment-emergent adverse events of any grade versus grade 3 or 4 with selinexor included:
-Nausea (151 [80.7%] vs. 11 [5.9])
-Decreased appetite (113 [60.4%] vs. 14 [7.5%])
-Fatigue (96 [51.3%] vs. 12 [6.4%])
Overall, 4 patients died in the selinexor arm and 3 patients died in the placebo arm.
The absence of CALB1 expression was associated with longer PFS with selinexor compared with placebo (median 6.9 vs. 2.2 months; HR, 0.19; P = 0.001).
Gounder MM, Razak AA, Somaiah N, et al. Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Oncol. 2022;doi: 10.1200/JCO.21.01829. Epub ahead of print. PMID: 35394800.
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